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U.S. Department of Health and Human Services

Class 2 Device Recall CARTOUNIVU MODULE

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  Class 2 Device Recall CARTOUNIVU MODULE see related information
Date Initiated by Firm February 12, 2014
Date Posted February 20, 2014
Recall Status1 Terminated 3 on May 23, 2014
Recall Number Z-1045-2014
Recall Event ID 67505
510(K)Number K120550  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124

WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.
Code Information Serial No. 13201, 11125, 11519, 11320, 11115.
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact
909-839-8500
Manufacturer Reason
for Recall		 Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.
FDA Determined
Cause 2		 Other
Action Biosense Webster sent an Urgent Field Safety Notice dated February 12, 2014, to all affected customers to inform them that Biosense Webster has become aware of an issue with a particular configuration of the CartoUnivu Module withn the Carto 3 System (v3.2.2 and v3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact their Biosense Webster sales representative or cal (866) 473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions about the acknowledgement form and its return, are instructed to call (909) 839-8468. For questions regarding this recall call 909-839-8500.
Quantity in Commerce 8 units total (5 units in US)
Distribution Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = BIOSENSE WEBSTER, INC.
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